IVD ELISA kit manufacturing is operating in an extremely competitive market. Not only the highest level of sensitivity and robustness is critical. Reagents are sought to be color-coded, easy to handle being Ready-To Use. The Protein Stabilizers need to the widest extent to be synthetic, without any content of BSA or other animal proteins. You need to differentiate yourself to your competitors.

Stabilizers are used in several levels of the ELISA Protocol:

After immobilizing the Ag or Ab to the ELISA plate, an effective Blocker following by a highly suitable Stabilizers is needed – Kem-En-Tec Diagnostics WellChampion does this in one step reducing water waste due to no need for washing between the steps

Standards and Controls need to be pre-diluted for easy use and for reducing handling mistakes. The Kem-En-Tec Diagnostics Protein-StabilPLUS is a preferred choice

A Conjugate Stabilizer for either HRP-Conjugates or AP-Conjugates again offers convenience and assay reproducibility offering the conjugates in a pre-diluted format. Kem-En-Tec Diagnostics offers a series of selected conjugate stabilizers for a versatile range of applications.

Conjugate stabilizers

Horseradish Peroxidase (HRP) and Alkaline Phosphatase (AP) are the most commonly used enzymes in immunoassays. In order to be used in the assay, HRP and AP molecules must first be conjugated to the detection antibody or antigen. The antibodies or antigens, conjugated with HRP or AP, either are stored at 2-8 ° C as a concentrated stock solution or diluted in an appropriate buffer to the desired assay dilution factor.

When diluted biomolecules or conjugates need to be stored for long time use, these buffers need stabilizing properties to maintain the molecular conformation and prevent loss of activity over time, finally providing ready-to-use working dilutions. Kem-En-Tec Diagnostics offers a series of different conjugate stabilizers with a stability lifetime of up to 4 years.

Characteristics:

BSA free

Free of azide, mercury or other toxic preservatives

Ready-to-use

Negligible batch-to-batch variations

HRP-StabilPLUS suitable for the dilution and stabilization of HRP-conjugatesAP-StabilPLUS suitable for the dilution and stabilization of AP-conjugatesUNI-StabilPLUS suitable for the dilution and stabilization of both HRP- and AP-conjugatesAntibody Enhancer also able to enhance the binding capacity of the diluted antibodies for increased sensitivity, yet an effective stabilizer.

ELISA GUIDE

In order to assist and inspire R&D employees, Kem-En-Tec Diagnostics has developed a comprehensive guide for ELISA Assay Development. The Guide takes the reader through the individual steps of an ELISA and provides Hint and Tips to each step.

The introduction presents the principle of the ELISA Assay, different basic types of ELISA Assays, modifications and combinations of these as well as describes the pro and cons of the different ELISA Assay protocols.

The last part includes an overview of suggestions to reagents with a view to optimize the ELISA Assay i.e. maximize ELISA Assay sensitivity, minimize ELISA Assay background and maximize ELISA Assay stability.

Environmental considerations during assay development

IVD manufacturers are working towards more environmentally conscious and sustainable manufacturing. Much of these efforts have been focusing on replacement of toxic chemicals for the protection of health of the employees. Kem-En-Tec Diagnostics supports these requirements, recommending ECO-friendly colorimetric substrates and reagents with no toxic preservative formulations.

Now also of highest priorities are reducing usage of facility water and energy use, reducing facility waste, increasing facility recycling, and sourcing recycled/recyclable product packaging. Kem-En-Tec Diagnostics´ Eco-sensible optionsare available for the development and production of diagnostics assays without compromising assay quality and stability. Further, those options can reduce production cost.

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